1. Field of the Invention
The present invention relates to new and useful improvements in toe splints and bunion correction devices and methods of application of the same. The present invention relates more particularly, to such a device comprising a thermoplastic splint and removable fastening means, and to a method which includes the molding of a themoplastic splint for custom fitting each patient and condition.
2. General Background
Treatment of a bunion by the medical profession most frequently requires the great toe be held in a position wherein the bones in the toe are in proper alignment.
Since the procedure often involves surgery, it is very important that the device to be used for holding the great toe in proper position be amenable to easy cleaning and not provide an environment conducive to the spread of infection.
It is also desirable, because of the many different sizes and shapes of feet to be treated, that the device for holding the great toe in position be readily adjustable to a wide variety of sizes and shapes.
When surgery is required, the device for holding the great toe in position must fit around the surgical dressing. And swelling may also result in changes in the size and shape of part of the foot. For the aforementioned reasons it is necessary in the present state of the art to maintain a large inventory of such devices on hand in order to appropriately fit all of the different sizes, shapes and conditions.
A bunion may cause the great toe to lie either over or under the second toe, making it desirable that the device for holding the great toe in position have the capacity for correcting this vertical deviation by holding the great toe at differing angles from the horizontal plane of the foot.
Various attempts have been made to fill the need for such a device. For example:
U.S. Pat. No. 1,785,185 issued to J. C. Day provides a foot encircling band and a toe encircling band having a pocket for a pad which serves to seperate the great toe and second toe;
U.S. Pat. No. 2,190,016 issued to J. C. Day, et al. provides both a toe and foot encircling band with a pocket of larger relative dimensions for padding which provides metatarsal support and gentle pulling action to cause the joint and toe to assume their normal positions;
U.S. Pat. No. 2,596,038 issued to M. B. Mayer provides a pocket for the great toe which is held in place by a plurality of straps;
U.S. Pat. No. 2,958,324 issued to W. Berkemann provides for a lever, one end of which can be made to exert pressure on the inside surface of the great toe by tightening the other end of the lever by an adjustable strap, the fulcrum being held in position by elastic webbing attached partially around the foot;
U.S. Pat. No. 1,175,718 issued to B. Crowe provides a solid member having a pocket for the great toe which is held in place by a securing strap;
Canadian Pat. No. 704,642 provides a unitary piece with a loop for the toe and a cushioning strip near the other end which wraps around the foot;
U.S. Pat. No. 1,665,030 issued to M. Hartwig provides for a solid member having a pocket for the great toe and secured by encircling the heel;
U.S. Pat. No. 3,219,032 issued to M. R. Levitt provides for two interconnected solid members, one of which has a loop for encircling the toe, the other fitting around the heel; and
U.S. Pat. No. 2,589,791 issued to W. W. Fine provides for a solid member fitting around part of the foot and having a loop for the great toe.
Although these patents have attempted to fill this need, until now none has been completely successful in providing a device which is easily modifiable to accomodate surgical dressing, to fit all shapes, sizes, and conditions, that has the capacity for holding the toe at differing angle from the horizontal plane of the foot, and which by reason of material of construction and surface texture is extremely easy to clean, to sterilize, and to maintain in a sterile condition.
Accordingly, there appears to be a longstanding need for an improved device which will overcome the aforementioned problems.